The other day, The Wall Street Journal's Health Blog asked the question "Is the FDA Too Easy On Medical Devices?" If so, it should further exacerbate device manufacturers' practice of introducing new devices in Europe before releasing them in the U.S.
For medical devices, there is no European approval authority like FDA. Instead, EU countries require medical devices to "CE Mark" their products. The CE Mark certifies that the product meets EU standards for health, safety, quality, and the environment. (Review our primer on European directives for more information.)
The CE Mark is more than just a rubber stamp, but earning it can be less of a hurdle compared to earning FDA approval. The specifics depend on the type of product though. A recent article in DOTmed said that
If the EU's process is faster, it's only so for Class 3 or Class 2 products (of which Europe has two, Class 2a and Class 2b; the latter's riskier), as the FDA makes minimal demands on Class 1The practice of first introducing some new devices in Europe has important implications for translations.
First, confidentiality is of particular importance. Client regularly approach us to translate packaging and instructions for new products. A typical translation effort can involve 60 contract linguists and formatters, and it is not uncommon for a client to remind us (or inquire) about the need for secrecy by every participant in the service-delivery chain.
Second, because these are no devices, reference materials are often sparse. In fact, they may be totally missing. This requires additional analysis up-front and a robust Q&A process during the translation phase.
Lastly, the lack of reference materials tends to also impact the client's in-country reviewers. Often, they hear about a new device for the first time when they receive it from us for review. In these situations, extra planning and communication are required to make sure that in-country reviews don't turn into a waste of time.
ForeignExchange Translations provides specialized medical translation and software localization services to drug and device companies. Contact us to learn more.